US6659981B2 - Medical device delivery catheter with distal locator - Google Patents

Abstract

A delivery catheter for delivering an intra-bodily medical device to an internal bodily site. The delivery catheter includes an elongated shaft defining a proximal section and a distal section. A delivery lumen is formed by the shaft, extending from the proximal section and terminating at an opening formed proximal the distal section. Finally, a locator is formed by the distal section, and is configured to locate a target site. In one preferred embodiment, the locator is elongated, having a diameter less than that of a remainder of the shaft. In another preferred embodiment, the delivery catheter includes a steering device capable of effectuating a bend both proximal and distal the opening for steering the locator to a target site.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to U.S. patent application Ser. No. 09/733,356, entitled “Ablation Catheter Assembly and Method for Isolating a Pulmonary Vein” filed on even day herewith, assigned to the same assignee, and incorporated herein by reference thereto.

BACKGROUND OF THE INVENTION

The present invention relates to a delivery catheter for guiding an elongated medical device to an internal bodily target site. More particularly, it relates to a delivery catheter forming a distal locator for locating the target site prior to deployment of an intra-bodily medical device.

A wide variety of medical procedures are performed at or within internal bodily vessels, channels, canals, or chambers. Due to the particular procedure and/or to minimize patient trauma, oftentimes the medical device useful for performing part or all of the procedure is introduced through a small incision into the bodily vessel, channel, canal, or chamber in question; or into a bodily vessel, channel, canal, or chamber that is otherwise connected to the site of interest (or target site), and then guided through that vessel to the target site. These types of medical devices are referred to herein generally as “intra-bodily medical devices”. For example, angioplasty procedures used to reduce arterial build-up include introducing a balloon-carrying catheter into a body vessel, such as a coronary artery, and maneuvering the catheter through the vessel to the target site. Similarly, one treatment of cardiac arrhythmia includes directing an ablation catheter through the inferior vena cava into the right atrium through a puncture in the interarterial septum and into the left atrium at which electrical isolation of a particular pulmonary vein can be achieved. A number of other medical procedures employ these same general protocols.

Regardless of the exact medical procedure, construction and operation of the requisite intra-bodily medical device typically requires that a separate guide device be employed to direct a distal segment (at which the operational portion of the intra-bodily medical device is typically located) to the target site. In other words, the particular intra-bodily medical device may not have sufficient rigidity to be easily advanced through body vessels, channels, canals, chambers, etc., and/or the distal segment might damage bodily tissue if left exposed during deployment to the target site. Thus, a guide catheter or sheath that coaxially maintains the intra-bodily medical device is normally employed to proficiently deliver the intra-bodily medical device, and in particular the distal segment thereof, to the target site. Following delivery of the guide catheter or sheath to the target site, the intra-bodily medical device is advanced distally or deployed to the target site through the guide catheter or sheath.

In addition, it is often times necessary to accurately locate the target site to ensure proper positioning of the distal end of intra-bodily medical device following deployment from the guide catheter or sheath. In this regard, the standard technique for locating a particular internal bodily site is use of a thin guide wire. The guide wire may be slidably disposed within a lumen formed by the intra-bodily medical device, or may be maintained by the guide catheter or sheath. In either case, the guide wire is relatively rigid and is “steered” by the surgeon to locate the target site. Once located, the intra-bodily medical device can then be deployed and accurately positioned.

While universally accepted, use of a guide wire to assist in locating a target site does have potential drawbacks. For example, because the guide wire is a component apart from the intra-bodily medical device and guide catheter or sheath, the opportunity for one of these components interfering with movement and/or operation of the other components is raised. Additionally, though guide wires are relative stiff, it is often times difficult to maneuver the distal end thereof to a desired location, especially at increased guide wire lengths and/or within relative confined areas.

A wide variety of intra-bodily medical devices are used to access and perform medical procedures on internal bodily sites. To this end, the accepted protocol of providing a separate guide body or sheath to deliver the intra-bodily medical device to the target site, as well as a separate guide wire for locating the target site is less than optimal. Therefore, a need exists for a unitary delivery catheter having a locator configured to assist in locating a target site.

SUMMARY OF THE INVENTION

One aspect of the present invention relates to a delivery catheter for delivering an intra-bodily medical device to an internal bodily site. The delivery catheter includes an elongated shaft defining a proximal section and a distal section. A delivery lumen is formed by the shaft, extending from the proximal section and terminating at an opening formed proximal the distal section. Finally, a locator is formed by the distal section, and is configured to locate a target site. In one preferred embodiment, the locator is elongated, having a diameter less than that of a remainder of the shaft. In another preferred embodiment, the delivery catheter includes a steering device capable of effectuating a bend both proximal and distal the opening for steering the locator to a target site.

Another aspect of the present invention relates to a catheter assembly for performing a medical procedure within an internal bodily site. The catheter assembly includes an intra-bodily medical device and a delivery catheter. The intra-bodily medical device has a distal end and is configured to perform a medical procedure. In this regard, a wide variety of intra-bodily medical devices are available, ranging from ablation catheter devices to angioplasty, fiber optics, basket catheters, etc. Regardless, the delivery catheter comprises an elongated shaft defining a proximal section and a distal section. A delivery lumen is formed by the shaft, extending from the proximal section and terminating at an opening proximal the distal section. In this regard, the delivery lumen is sized to slidably receive the intra-bodily medical device. Finally, a locator is formed by the distal section and is configured to locate a target site. With this configuration in mind, the intra-bodily medical device is slidably disposed within the delivery lumen, and is moveable between a retracted position in which the distal end of the intra-bodily medical device is proximal of the opening and a deployed position in which the distal end is distal the opening. During use, the delivery catheter guides the intra-bodily medical device, in the retracted position, to a target site. The locator is employed to locate the target site. Finally, the intra-bodily medical device is maneuvered to the deployed position to perform a medical procedure.

Yet another aspect of the present invention relates to a method of deploying an intra-bodily medical device to an internal bodily target site. The method includes providing a delivery catheter including an elongated shaft having a proximal section, an intermediate section, a distal locator, and a delivery lumen. The delivery lumen extends from the proximal section to an opening formed proximal the distal locator. An intra-bodily medical device having a distal end is also provided. The delivery catheter is deployed so as to position the distal locator adjacent the target site. The target site is located with the distal locator. The elongated medical device is advanced in a distal fashion within the delivery lumen such that the distal end is deployed distally beyond the opening for performing a medical procedure on the target site. Finally, the intra-bodily medical device is retracted in a proximal fashion within the delivery lumen such that the distal end is retracted proximal the opening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a delivery catheter in accordance with the present invention;

FIG. 2A is an enlarged, cross-sectional view of the delivery catheter of FIG. 1 along theline2A—2A;

FIG. 2B is an enlarged, cross-sectional view of the delivery catheter of FIG. 1 along theline2B—2B;

FIG. 2C is an enlarged, side view of a distal portion of the delivery catheter of FIG. 1;

FIG. 2D is an enlarged, cross-sectional view of the delivery catheter of FIG. 1 along theline2D—2D;

FIG. 3 is a perspective view of a catheter assembly including the delivery catheter of FIG. 1 in conjunction with an elongated medical device;

FIG. 4 is a side, perspective view of a catheter assembly including the delivery catheter of FIG.1 and an alternative elongated medical device;

FIGS. 5A-5C illustrate deployment of an elongated medical device with the delivery catheter of FIG. 1 within a heart in accordance with the present invention; and

FIG. 6 is a side view of the delivery catheter of FIG. 1, illustrating steering capabilities.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

One preferred embodiment of adelivery catheter10 in accordance with the present invention is shown in FIG.1. Thedelivery catheter10 includes aproximal section12, anintermediate section14, and adistal section16. Theintermediate section14 extends from theproximal section12 and terminates at anopening18. Thedistal section16 extends from theintermediate section14 distal theopening18. As described in greater detail below, thedistal section16 forms alocator20. As a point of reference, in the preferred embodiment of FIG. 1, thelocator20 is defined by an entirety of thedistal section16. Regardless, thedelivery catheter10 is configured for delivering an intra-bodily medical device (not shown) to an internal bodily site, and thus forms a delivery lumen (not shown) extending from theproximal section12 to theopening18. In this regard, and as described in greater detail below, thedelivery catheter10 is preferably steerable both proximal and distal theopening18.

In light of the preferred steerable attribute of thedelivery catheter10, theproximal section12 preferably includes a Y-connector30 coupled to ahandpiece32 and ahemostatic valve34. Thehandpiece32 is of a type known in the art and providescontrol devices36, the operation of which (i.e., rotation) effectuates desired bending of thedelivery catheter10 via pull wires (not shown) described in greater detail below. Thehemostatic valve34 is fluidly connected to the delivery lumen (not shown) and preferably forms afirst port38 and asecond port40. Thefirst port38 is available for receiving and directing an intra-bodily medical device or other elongated body (not shown) to the delivery lumen. Further, thesecond port40 is also fluidly connected to the delivery lumen, and is available for delivering a fluid to the delivery lumen. For example, in one preferred embodiment, atube42 extends from thesecond port40 to astop cock valve44. as is known in the art, thehemostatic valve34 in conjunction with thestop cock valve44 allows flushing of a liquid, such as saline, through the delivery lumen, while preventing a back flow of other liquids, such as blood.

With further reference to FIG. 2A, theproximal section12 forms thedelivery lumen50 described above. In addition, theproximal section12 forms apassage52 surrounding thedelivery lumen50 and maintaining, as depicted in FIG. 2A, afirst pull wire54, asecond pull wire56 and a cluster ofelectrode wires58. In one preferred embodiment, thedelivery lumen50 is defined by atube60 co-axially disposed within thepassage52. Alternatively, theproximal section12 can be configured to integrally form thedelivery lumen50. Thefirst pull wire54 extends from thehandpiece32 to theintermediate section14 for effectuating steering or bending of thedelivery catheter10 proximal theopening18. Thesecond pull wire56 extends from thehandpiece32 to thedistal section16 for effectuating steering or bending of thedelivery catheter10 distal theopening18. Finally, the cluster ofelectrode wires58 are electrically connected to an auxiliary energy source (not shown) for energizing various electrodes associated with thedelivery catheter10, as described in greater detail below.

Theproximal section12 is preferably formed of a reinforced, braided material such as a tubular shaft constructed of “Ultem” polyamide, or other high temperature polymer covered with a reinforcing braid wire or high strength filament and jacketed by a flexible polymer such as nylon, polyurethane, or “PEBAX”™. With this preferred material, theproximal section12 exhibits enhanced torqueability, such that a user can more easily steer or guide thedelivery catheter10 to a target site.

Theintermediate section14 forms theopening18 and preferably maintains anelectrode61. With additional reference to FIG. 2B, theintermediate section14 defines first, second, and third lumens62-66, in addition to thedelivery lumen50. Thedelivery lumen50 is preferably defined by thetube60 otherwise carried within theintermediate section14. Alternatively, thedelivery lumen50 can be integrally formed by theintermediate section14. Once again, thedelivery lumen50 is available to slidably maintain an intra-bodily medical device (not shown) or other body, and terminates at theopening18. Thefirst pull wire54 extends through thefirst lumen62 and is secured to theintermediate section14 adjacent theopening18. Thesecond pull wire56 extends through thesecond lumen64. Finally, the cluster ofelectrode wires58 are maintained within thethird lumen66.

Theelectrode61 is preferably a band electrode electrically connected to one or more of the cluster ofelectrode wires58. With this configuration, theelectrode61 is available as a mapping electrode. Notably, however, theelectrode61 is not a necessary element of thedelivery catheter10.

Theintermediate section14 is preferably formed of a material different from that of theproximal section12. More particularly, unlike the preferably reinforced, torqueable composition of theproximal section12, theintermediate section14 is preferably comprised of a softer material such as nylon, polyurethane, or “PEBAX”™. With this configuration, theintermediate section14 is highly amenable to bending via tensioning of thefirst pull wire54. To this end, a length of the intermediate section14 (i.e., longitudinal distance proximal the opening18) dictates the focal point at which bending of theintermediate section14 occurs, as well as an available bend radius. In a preferred embodiment, theintermediate section14 has a longitudinal length in the range of 5-24 cm, more preferably 15 cm.

Theopening18 is shown more clearly in FIG.2C. The opening is defined by anouter edge70 extending from aproximal end72 to adistal end74. In a preferred embodiment, theedge70 is rounded or curved so as to minimize tissue damage as thedelivery catheter10 is passed through bodily lumens, for example veins. Alternatively, however, theopening18 may assume a wide variety of other forms. Further, as described below, a rounded-tip dilator (not shown) is preferably extended into and/or through theopening18 to further minimize the opportunity for tissue damage during deployment.

Thedistal section16 extends distally beyond theopening18, forming thelocator20. In one preferred embodiment, thelocator20 extends the entire length of thedistal section16, although thelocator20 may have a length less than that of thedistal section16. Further, in one preferred embodiment, thedistal section16 includes electrode pairs80aand80band terminates at atip82 that, in one preferred embodiment, incorporates a thermocouple and serves as an electrode pair with anelectrode84. With additional reference to FIG. 2D, thedistal section16, including thelocator20, defines thesecond lumen64, maintaining thesecond pull wire56, and thethird lumen66, maintaining the cluster ofelectrode wires58. Thesecond pull wire56 is attached to thelocator20 adjacent thetip82. The cluster ofelectrode wires58 are connected to the pairs ofelectrodes80aand80b,as well as thetip82 and theelectrode84. With this configuration, the electrode pairs80aand80b,as well as thetip82 and theelectrode84, are available for mapping and/or ablation functions. Theelectrodes80a,80b,82,84 are preferably band electrodes, although other constructions are equally acceptable. Even further, one or more of theelectrodes80a,80b,82,84 can be eliminated.

Thedistal section16, including thelocator20, is preferably formed from a soft material similar to theintermediate region14, preferably nylon, polyurethane, or “PEBAX”™. With this configuration, thelocator20 is bendable or steerable via tensioning of thesecond pull wire56. As is illustrated best in FIG. 1, thelocator20 is preferably formed to an outer diameter less than that of theintermediate section14 and theproximal section12. In one preferred embodiment, thelocator20 has an outer diameter in the range of 5-7 French, more preferably 6 French, whereas theintermediate section14 has a diameter in the range of approximately 10-13 French. Further, thelocator20 extends an appreciable distance distal theopening18 so as to provide sufficient surface area for locating a target site. With this in mind, in one preferred embodiment, thelocator20 has a length in the range of 5-20 cm, more preferably 15 cm.

The above-describeddelivery catheter10 is available to deliver a wide variety of different intra-bodily medical devices to an internal bodily site. For example, FIG. 3 depicts thedelivery catheter10 in conjunction with anablation catheter90 useful for ablating an enclosed pattern about a pulmonary vein ostium for treatment of cardiac arrhythmia. Theablation catheter90 includes adistal region92 and is slidably disposed within thedelivery lumen50 otherwise formed by thedelivery catheter10. Use and operation of thedelivery catheter10 is independent of the construction and operation of theablation catheter90, therefore, theablation catheter90 need not be described in detail. In general terms, thedistal region92 of theablation catheter90 is configured to ablate contacted tissue, such as by activation of one or more electrodes (not shown). Regardless, theablation catheter90 is moveable within thedelivery lumen50 between a deployed position (shown in FIG. 3) in which thedistal region92 is advanced distal theopening18, and a retracted position (not shown) in which thedistal region92 is retracted proximal theopening18.

Thedelivery catheter10 can be used with a wide variety of other intra-bodily medical devices different from theablation catheter90. For example, FIG. 4 depicts thedelivery catheter10 in conjunction with aballoon catheter100. Once again, theballoon catheter100 is slidably disposed within thedelivery lumen50, movable between a deployed position (shown in FIG. 4) and a retracted position relative to theopening18. As is further exemplified by the example of FIG. 4, a central axis of thelocator20 is preferably parallel with a central axis of thedelivery lumen50. With this preferred configuration, the intra-bodily medical device (e.g., the balloon catheter100) is deployed parallel with, and in close proximity to, thelocator20, so that thelocator20 will more easily guide the intra-bodily medical device upon deployment thereof.

A number of other intra-bodily medical devices are equally acceptable for use with thedelivery catheter18, including intra-vascular ultrasound devices, intra-cardiac echo devices, angiographic devices, balloon angiography devices, fiber optic devices, biopsy devices, cryo-catheter devices, electrophysiology catheter devices, basket mapping catheter devices, thermal therapy balloon devices, device retrieving catheters, etc.

Use of thedelivery catheter10 is dependent upon the particular medical procedure to be performed, and thus the particular intra-bodily medical device carried by thedelivery catheter10. For example, where the medical procedure is heart tissue ablation for treatment of cardiac arrhythmia, an ablation catheter, such as theablation catheter90 depicted in FIG. 3, must be deployed within the heart. For this one specific example, FIGS. 5A-5C illustrate use of thedelivery catheter10 within aheart150 in conjunction with an ablation catheter. As a point of reference, theheart150 includes a right atrium RA, a left atrium LA, a right ventricle RV, and a left ventricle LV. An inferior vena cava IVC and a superior vena cava SVC lead into the right atrium RA. The right atrium RA is separated from the left atrium LA by an interarterial septum (not shown). Finally, four pulmonary veins PV extend from the left atrium LA. Each of the pulmonary veins PV forms an ostium PVO in the left atrium LA wall. During formation of theheart150, it is possible that tissue of the left atrium LA may grow upwardly into one or more of the pulmonary veins PV. This left atrium LA tissue may spontaneously depolarize, resulting in atrial fibrillation. This malady is treatable by ablating tissue about the associated pulmonary vein ostium PVO to electrically isolate the depolarizing tissue.

As shown in FIG. 5A, electrical isolation of a pulmonary vein PV includes directing thedelivery catheter10 toward the target site (e.g., the pulmonary vein ostium in question). In particular, thedistal section16 of thedelivery catheter10 is directed through the inferior vena cava IVC, into the right atrium RA through a puncture in the interarterial septum (not shown) and into the left atrium LA. Alternatively, the introduction of thedistal section16 of thedelivery catheter10 into the right atrium RA is also suggested by passage of thedistal section16 into the right atrium RA through the superior vena cava SVC. In one preferred embodiment, prior to placement within the patient, a rounded-tip dilator152 is slidably disposed within the delivery lumen50 (FIG.1), adistal end154 of which extends at least partially out of theopening18. By providing thedilator152, thedelivery catheter10 can be fed through bodily lumens, such as veins, without damaging tissue at theopening18.

Once theintermediate section14 and thedistal section16, including thelocator20, have been guided to the general area of interest (e.g., the left atrium LA), the rounded-tip dilator152 is removed from thedelivery lumen50, and the intra-bodily medical device, for example theablation catheter90, inserted therein.

Thelocator20 of thedelivery catheter10 is then maneuvered to locate the target site. With respect to the one example of FIGS. 5A-5C in which an ablation pattern is to be formed about a pulmonary vein ostium PVO, the target site is the associated pulmonary vein PV. Thus, thelocator20 is directed into the pulmonary vein PV to locate the pulmonary vein ostium PVO, as shown in FIG.5B. To this end, an available visualization device, such as a fluoroscope, can be employed to confirm placement of thelocator20 within the pulmonary vein PV. Further, the various electrodes, including theelectrodes80a,80b,82 and/or84 provided along thelocator20 can be selectively activated and their signals reviewed to further confirm placement of thelocator20 within the pulmonary vein PV, as well as to evaluate electrical activity at the target site.

Once the target site has been located with thelocator20, theablation catheter90 is advanced to a deployed position in which thedistal region92 extends distal theopening18. Theablation catheter90 is further advanced so as to position thedistal region92 against the target site (e.g., about the pulmonary vein ostium PVO), as shown in FIG.5C. In this regard, thelocator20 serves as a guide to facilitate proper positioning of thedistal region92, as well as anchoring thedelivery catheter10, and thus theablation catheter90, relative to the target site. While with the one specific example provided in FIGS. 5A-5C, thedistal region92 of theablation catheter90 forms a helix that engages, and is thus directly guided by, thelocator20, such an arrangement is not required. In other words, thelocator20 need not specifically contact or otherwise engage the intra-bodily medical device to generally direct the distal region (such as the distal region92) to the target site. Additionally it is not required that thelocator20 locate the target site prior to deployment of the intra-bodily medical device (e.g., the ablation catheter90). That is to say, the intra-bodily medical device (e.g., the ablation catheter90) can be deployed first, and then the target site be located with thelocator20.

Once properly positioned, the intra-bodily medical device, such as theablation catheter90, is operated to perform the desired medical procedure. For example, with reference to the one specific example of FIGS. 5A-5C, theablation catheter90 is operated to ablate a continuous pattern about the pulmonary vein ostium PVO, thereby electrically isolating the pulmonary vein PV from theheart150. Following completion of the medical procedure, the intra-bodily medical device, such as theablation catheter90, is retracted within the delivery lumen50 (FIG. 1) such that the distal region (such as the distal region92) is no longer “exposed”. Thedelivery catheter10 is then removed from the patient. Alternatively, other similar medical procedures can be performed at the target site or other target sites (e.g., electrical isolation of other pulmonary vein ostia PVOs). In this regard, the intra-bodily medical device (such as the ablation catheter90) can be repeatedly used or can be replaced by another device configured to perform a different medical procedure. In either case, thelocator20 is available for locating the target site and generally guiding the medical device into a proper position.

Once again, the medical procedure described with respect to FIGS. 5A-5C is but one procedure for which thedelivery catheter10 is applicable. Other medical procedures can be performed with thedelivery catheter10 at different internal bodily sites with entirely different intra-bodily medical devices. Regardless, thelocator20 is utilized to locate the target site generally anchor thedelivery catheter10, and guide the intra-bodily medical device in question to a proper position relative to the target site.

Often times, the particular target site for which thedelivery catheter10 is to be deployed requires relatively radical articulation or steering of thedelivery catheter10 to properly position thelocator20. For example, with reference to the cardiac arrhythmia treatment procedure described above, following deployment into the left atrium LA via the interarterial septum, the right pulmonary veins RPVs are effectively located “behind” thelocator20, such that it is impossible to position thelocator20 within one of the right pulmonary veins RPVs by simply advancing thedelivery catheter10 forward. Instead, thedelivery catheter10 must be steered to properly position thelocator20. In this regard, FIG. 6 depicts steering capabilities of thedelivery catheter10 in accordance with one preferred embodiment. Thedelivery catheter10 is preferably configured to effectuate bends both proximal and distal of theopening18. For example, the first pull wire54 (FIG. 2A) can be tensioned to effectuate a major bend at the intermediate section14 (or proximal the opening18). This “gross” bend provided proximate of theopening18 generally positions thelocator20.

Conversely, thesecond pull wire56 can be tensioned to effectuate a bend in the locator20 (or distal the opening18). Steering of thelocator20 provides exacting control of a position of thelocator20. As will be recognized by one of skill in the art, steering means other than pull wires can be employed to effectuate the preferred bends proximal and distal theopening18.

Thedelivery catheter10 of the present invention provides a marked improvement over previous designs. In particular, the delivery catheter combines the performance attributes of a delivery sheath and guide wire into a single, unitary device. Further, by configuring the delivery catheter to be steerable both proximal and distal the opening through which the intra-bodily medical device is deployed, rapid engagement of a target site is promoted.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present invention. For example, the delivery catheter has been preferably described as incorporating a series of electrodes or electrode pairs along the distal section thereof. Alternatively, where a particular medical procedure does not require mapping or similar functions, the electrode or electrode pairs can be eliminated and therefore are not necessary elements.

Claims (16)

What is claimed is:

1. A delivery catheter for delivering an intra-bodily medical device to an internal bodily site, the delivery catheter comprising:

an elongated shaft including a proximal section, an intermediate section extending from the proximal section, and a distal section extending from the intermediate section along a first central axis and forming a locator configured to locate and be positioned at a target site; and

a delivery lumen, formed by the shaft, extending from the proximal section along a second central axis and terminating at an opening formed proximal the distal section, wherein the first central axis is offset from and parallel to the second central axis and the intra-bodily medical device is insertable within the delivery lumen and directed by the distal section to be positioned at the target site as the intra-bodily medical device is advanced through the delivery lumen and outward from the opening.

2. The delivery catheter ofclaim 1, wherein the delivery lumen is configured to slidably receive an intra-bodily medical device, and further wherein the opening is configured to allow selective deployment of at least a portion of an intra-bodily medical device relative to the opening.

3. The delivery catheter ofclaim 1, wherein the elongated shaft is configured such that the locator is bendable.

4. The delivery catheter ofclaim 3, further comprising:

locator steering means for selectively bending the locator distal the opening.

5. The delivery catheter ofclaim 4, wherein the locator steering means includes at least one pull wire extending from the proximal section and terminating within the distal section.

6. The delivery catheter ofclaim 4, wherein the locator steering means includes at least one pull wire extending from the proximal section to the intermediate section, the pull wire terminating within the intermediate section.

7. The delivery catheter ofclaim 3, wherein the proximal section is formed of a first material and the locator is formed of a second material, the first material being stiffer than the second material.

8. The delivery catheter ofclaim 3, wherein the proximal section is formed of a first material and the intermediate section is formed of a second material, the first material being stiffer than the second material.

9. The delivery catheter ofclaim 1, wherein the locator has a diameter less than a diameter of the intermediate section.

10. The delivery catheter ofclaim 1, wherein the locator has a length of at least 5 cm.

11. The delivery catheter ofclaim 1, wherein the opening is defined by an edge extending from a proximal end to a distal end, and further wherein the edge is curved.

12. The delivery catheter ofclaim 1, further comprising:

an elongated dilator forming a rounded tip, the elongated dilator being configured for selective placement within the delivery lumen such that the rounded tip selectively extends at least partially from the opening.

13. The delivery catheter ofclaim 1, further comprising an electrode positioned along the locator performing one of mapping, ablation, and mapping and ablation functions.

14. The delivery catheter ofclaim 13, further comprising a mapping electrode positioned along the intermediate section of the shaft.

15. The delivery catheter ofclaim 3, further comprising:

an actuating device positioned along the proximal section of the shaft;

a first pull wire extending from the actuating device to the intermediate section of the shaft effectuating bending along the intermediate section of the shaft through the actuating device; and

a second pull wire extending from the actuating device to the distal section of the shaft effectuating bending along the distal section of the shaft through the actuating device.

16. The delivery catheter ofclaim 14, further comprising:

an actuating device positioned along the proximal section of the shaft;

a first pull wire extending from the actuating device to the intermediate section of the shaft effectuating bending along the intermediate section of the shaft through the actuating device; and

a second pull wire extending from the actuating device to the distal section of the shaft effectuating bending along the distal section of the shaft through the actuating device.

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